SmallpoxPhase 3NCT04971109

Safety, Tolerability and Pharmacokinetics of TPOXX When Administered Orally for 28 Days

A Phase 3 study testing TPOXX in people with Smallpox, run by SIGA Technologies at 9 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

This is a study to assess the safety, tolerability, and PK of oral TPOXX 600 mg when administered twice daily (BID) for 28 days in adult subjects. Read more about this study

Who is it for?: Ages 18 to 80 yearsHealthy volunteers can take part
Conditions the study is for: Smallpox
What is being tested?: TPOXX
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 467 participants
Where: 9 sitesUnited States
Study dates: 29 Mar 2022to 12 May 2023
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 80 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Subject is male or female between 18 and 80 years of age, inclusive.
Subject is available for clinical follow-up for the duration of the study.
Women of childbearing potential have a negative beta human chorionic gonadotropin pregnancy test (serum) at the screening visit and a confirmatory negative pregnancy test on Day 1 or Day -1 (PK subset) before receipt of study drug, and meet one of the following criteria:
Subject or their partner has undergone surgical sterilization.
Subject is postmenopausal, defined as 12 consecutive months with no menses without an alternative medical cause and has a documented plasma follicle stimulating hormone level >40 IU/mL.
Subject agrees to be abstinent (ie, heterosexually inactive) for the duration of the study.

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Subject agrees to consistently use 1 of the following methods of contraception from the beginning of screening (which they had been consistently using for at least 30 days before the first dose of study drug) through 30 days after the last dose of study drug:
Condoms, male or female, with a spermicide NOTE: For male subjects, condoms must be used for 90 days after the last dose of study drug. Male and female condoms should not be used together, as this can reduce their effectiveness.
Diaphragm or cervical cap with spermicide iii. Intrauterine device with spermicide iv. Oral contraceptives or other hormonal methods NOTE: Another nonhormonal method of contraception must be used in conjunction with oral contraceptives.
Male sexual partner who had undergone a vasectomy at least 3 months before screening
Male subjects must agree to not donate sperm from the first dose of study drug through 90 days after the last dose of study drug.
Subject is considered by the investigator to be in good general health as determined by medical history (no hospitalizations for chronic medical conditions in the previous 2 years), clinical laboratory test results, vital sign measurements, 12-lead ECG results, and physical examination findings at screening.
Subject agrees not to use nicotine products, including electronic vapor cigarettes, nicotine patches, or nicotine gum, for at least 30 days before the Day 1 randomization visit through completion of the Day 29 dosing complete/early termination (ET) visit.
Subject agrees to comply with the study dietary requirements throughout the study drug dosing period.
Subject agrees not to consume caffeine- or xanthine-containing products during all study visits, including overnight stays (PK subset); sodas, coffee, and tea designated as caffeine free or noncaffeinated may be consumed on study days; caffeine may be consumed while at home and between study visits.
Subject agrees to comply with all protocol requirements.
Subject has adequate venous access if participating in the PK subset.
Subject is able and willing to provide written informed consent.

Who cannot join

Subject is a female who is pregnant or breastfeeding or planning to become pregnant within 3 months after the last dose of study drug.
Subject has a history of any clinically significant conditions including:
Asthma treated with oral systemic steroids within the past 6 months
Diabetes mellitus (type 1 or 2), with the exception of gestational diabetes
Hypertension that is poorly controlled (repeat readings >140 mm Hg systolic and/or >90 mmHg diastolic)
Thyroidectomy or thyroid disease that required medication within the past 12 months

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Serious angioedema episodes within the previous 3 years or requiring medication in the previous 2 years
History of head trauma resulting in a diagnosis of traumatic brain injury other than concussion
Frequent episodes of headache
Subject has received any vaccination within 28 days prior to Day 1 or plans to receive a vaccination at any time during the treatment period or within 28 days after study Day 28.
Subject has received treatment in another clinical study of an investigational drug (or medical device) or investigational vaccine within 30 days or 5 half-lives (whichever is longer) before the first dose of study drug.
Subject has a history of relevant drug and/or food allergies (ie, allergy to TPOXX or excipients, or any significant food allergy that could preclude a standard diet in the clinical investigative site).
Subject has any condition possibly affecting drug absorption (eg, previous surgery on the gastrointestinal tract, including removal of parts of the stomach, bowel, liver, gallbladder, or pancreas, with the exception of appendectomy).
Subject has evidence or history of clinically significant allergic (except for untreated, asymptomatic, seasonal allergies at time of the first dose of study drug), hematological, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, or neurological disease. Exceptions to these criteria (eg, stable, mild joint disease unassociated with collagen vascular disease) may be made following discussions with the medical monitor.
Subject has a history of cardiac disease, symptomatic or asymptomatic arrhythmias, syncopal episodes, or risk factors for torsades de pointes (eg, heart failure, hypokalemia).
Subject has a family history of sudden cardiac death not clearly due to acute myocardial infarction.
Subject is 20 years of age or older and has a ≥10% risk of developing a myocardial infarction or coronary death within the next 10 years using the National Cholesterol Education Program's Risk Assessment Tool: www.mcw.edu/calculators/ldl-cholesterol-goal-level.
Subject has a seizure disorder or history of seizures (does not include childhood febrile seizures) or a past history that increases seizure risks such as significant head injury that caused loss of consciousness or other changes in the subject's daily function, concussion, stroke, central nervous system infection or disease, or alcohol or drug abuse or family history of idiopathic seizures.
Subject has a history of a peptic ulcer or significant gastrointestinal bleeding.
Subject has a bleeding disorder diagnosed by a doctor (eg, factor deficiency, coagulopathy, or platelet disorder requiring special precautions) or significant bruising or bleeding difficulties with blood draws.
Subject has a malignancy that is active or treated malignancy for which there is not reasonable assurance of sustained cure, or malignancy that is likely to recur during the period of the study (subject should be in complete remission for at least 5 years).
Subject has neutropenia or other blood dyscrasia determined to be clinically significant by the investigator.
Subject has used any of the following prohibited medications from within 7 days (or 5 half lives, whichever is longer) before the first dose of study drug: antidiabetic medication; anticoagulants; anticonvulsants; substrates of the breast cancer resistance protein transporter including methotrexate, mitoxantrone, imatinib, irinotecan, lapatinib, rosuvastatin, sulfasalazine, and topotecan; substrates of cytochromes (CYP)2C8 including repaglinide, paclitaxel, montelukast, pioglitazone, rosiglitazone; and substrates of CYP2C19 including S-mephenytoin, clobazam, diazepam, rabeprazole, voriconazole, lansoprazole, and omeprazole. Medications not listed here that are known (or thought) to be CYP3A4 substrates may be allowed at the investigator's discretion, after consultation with the medical monitor, if administration poses little to no risk to the subject.
Subject has a history of drug or alcohol abuse or dependency within the last year before screening.
Subject has a current or recent (<30 days before screening) history of clinically significant bacterial, fungal, or mycobacterial infection.
Subject has a current clinically significant viral infection.
Subject has a known clinically significant chronic viral infection (eg, human T cell lymphotropic virus I or II).
Subject demonstrates long-term use (≥14 consecutive days) of glucocorticoids, including oral or parenteral prednisone or equivalent (>20 mg total dose per day), or high dose inhaled steroids (>800 mcg/day of beclomethasone dipropionate or equivalent) within the preceding 1 month (low dose [≤800 mcg/day of beclomethasone dipropionate or equivalent] inhaled and topical steroids are allowed).
Subject has donated >450 mL blood or blood components within 30 days before the first dose of study drug. The investigator should instruct subjects who participate in this study to not donate blood or blood components for 4 weeks after the completion of the study.
Subject reports participation in strenuous activity or contact sports within 24 hours before the first dose of study drug.
Subject has known hepatitis B or C infection or positive test for hepatitis B surface antigen, hepatitis C virus antibody, or human immunodeficiency virus type 1 or 2 antibodies at screening.
Subject has a positive test result for amphetamines (including methamphetamines and ecstasy/methylenedioxymethamphetamine), barbiturates, benzodiazepines, cannabinoids (including tetrahydrocannabinol), cocaine metabolites, opiates (including heroin, codeine, and oxycodone), cotinine, or alcohol at screening or check-in.
Subject has any of the following laboratory test results within 28 days before the first dose of study drug:
Estimated serum creatinine clearance (Cockcroft Gault) <70 mL/min
Creatinine in males >1.7 mg/dL and in females >1.4 mg/dL (1.3 times the upper laboratory reference range)
Hemoglobin ≤10% of the lower laboratory reference range
White blood cell counts considered to be clinically significant by the investigator
Absolute neutrophil count <1000 cells/mm3
Platelets not within ±10% of laboratory reference range
Alanine aminotransferase >2 times above the upper laboratory reference range
Aspartate aminotransferase >2 times above the upper laboratory reference range
Alkaline phosphatase >20% above the upper laboratory reference range
Hemoglobin A1c ≥7.0%
Cholesterol ≥300 mg/dL and low density lipoprotein ≥190 mg/dL
Subject has a blood pressure considered to be clinically significant by the investigator. Blood pressure may be retested twice in the sitting position at 5-minute intervals.
Subject has a resting heart rate of <40 beats per minute or >110 beats per minute at screening.
Subject has an abnormal ECG at screening that is determined by the investigator to be clinically significant.
Male subject has a QT interval corrected using Fridericia's formula (QTcF) >450 ms or female subject has a QTcF >470 ms at screening or Day 1, or Day -1 (PK subset).
Subject has used any prescription antiviral drugs with the intention of coronavirus disease (COVID 19) prophylaxis, including those that are thought to be effective for prevention of COVID 19 but have not been licensed for this indication, within 1 month prior to study entry or during the study.
Subject is at a high risk of contracting SARS-CoV-2/COVID-19 infection, including, but not limited to, individuals with known close contact with:
Anyone residing in, visiting, or working at a health care or long-term care institution (ie, long-term care facilities, acute care hospitals, rehabilitation hospitals, mental health hospitals, emergency departments)
Anyone with known history of COVID-19 within 2 weeks prior to study entry
Anyone who traveled outside the United States or has recently traveled outside of the state and has returned from a state that is listed on a travel advisory list requiring quarantine for any duration within 30 days before study entry
In the opinion of the investigator, the subject is not suitable for entry into the study.
Subject is a member or family member of the investigator or study site personnel.
Subject has previously participated in this or any other clinical trial involving TPOXX (tecovirimat).

Trial locations and contacts

9 sites in 1 country.

City, postcode or hospital

9 sites in 1 country

United States9 sites

PPD Phase I Clinic
Austin, Texas, 78744
Hassman Research Institute
Berlin, New Jersey, 08009
Midwest Clinical Research Center
Dayton, Ohio, 45417
High Point Clinical Trials Center
High Point, North Carolina, 27265
Clinical Pharmacology of Miami, LLC
Miami, Florida, 33014
Advanced Pharma
Miami, Florida, 33147
Coastal Carolina Research Center
North Charleston, South Carolina, 29405
Meridian Clinical Research
Omaha, Nebraska, 68134-3664
Orlando Clinical Research Center
Orlando, Florida, 32809

Other trials in United States

About this study

Official title: A Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Assess the Safety, Tolerability, and Pharmacokinetics of TPOXX When Administered Orally for 28 Days in Adult Subjects

This is a study to assess the safety, tolerability, and PK of oral TPOXX 600 mg when administered twice daily (BID) for 28 days in adult subjects.

Read the detailed description

This is a Phase 3, multicenter, double-blind, randomized, placebo-controlled study to assess the safety, tolerability, and PK of oral TPOXX 600 mg when administered BID for 28 days in adult subjects.

Conditions: Smallpox
Being tested: TPOXX, TPOXX Placebo
Medical subject headings: Smallpox

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

TPOXXDrug
Also called tecovirimat
Study is based on Animal Regulatory Rule
TPOXX PlaceboOther
Also called Placebo
Does not apply

Study groups in NCT04971109
Study group	Role	What they receive
TPOXX	Active comparator	Treatment Group 1: An oral dose of 600 mg (3 x 200 mg capsules)TPOXX Receives: Drug: TPOXX
TPOXX Placebo	Placebo comparator	Treatment Group 2: An oral dose of placebo (3 capsules identical to TPOXX) Receives: Other: TPOXX Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Cmin
Cmin - Minimum TPOXX concentration in plasma
Measured: 28 days
Cmax
Peak exposure when administered TPOXX
Measured: 28 days
AUC(0-last) - Total Systemic TPOXX Exposure
Total systematic exposure when administered TPOXX
Measured: 28 days
Time To Maximum TPOXX Exposure
Median hours post dose when administered TPOXX
Measured: 28 days

Secondary outcomes (1)

Adverse Events
Number of participants with adverse events (Threshold: >/=2%)
Measured: 58 Days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

29 Mar 202212 May 2023

First posted21 Jul 2021
Study start29 Mar 2022
Primary completion12 May 2023
Study completion12 May 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for SmallpoxStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 467 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04971109
Sponsor's protocol ID: SIGA-246-024
Other IDs: MCDC1901-001
Status last verified: Oct 2024
First submitted: 23 Jun 2021
Last updated: 11 Sep 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No
Expanded access: Available

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingPhase 2
Study to Assess the Safety and Immunogenicity of TPOXX® When Administered Orally for 28 Days With JYNNEOS
Smallpox
Active, not recruitingPhase 4
Smallpox Vaccine for Mpox Post-Exposure Prophylaxis: A Cluster RCT
Monkeypox
RecruitingPhase 2
A Randomized Clinical Trial Investigating the Safety, Reactogenicity, and Immunogenicity After Immunization With an mRNA-based Mpox Vaccine Candidate in Africa
Mpox (Monkeypox), Smallpox
Enrolling by invitationObservational study
VA-005 Clinical Outcomes of VIGIV Treatment of Smallpox Vaccination Complications or Vaccinia Infection
Complication of Smallpox Vaccination
Active, not recruitingPhase 3
Phase 3 Infant Safety & Immunogenicity Trial of MVA-BN® in DRC
Mpox (Monkeypox), Vaccination

All Smallpox trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Assess the Safety, Tolerability, and Pharmacokinetics of TPOXX When Administered Orally for 28 Days in Adult Subjects
ClinicalTrials.gov ID: NCT04971109
Acronym / sponsor ID: SIGA-246-024
Conditions: Smallpox
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 467 participants (actual)
Lead sponsor: SIGA TechnologiesIndustry (pharma, biotech, devices)
Collaborators: United States Department of Defense
Study start: 29 Mar 2022 (actual)
Primary completion: 12 May 2023 (actual)
Study completion: 12 May 2023 (actual)
First posted: 21 Jul 2021 (actual)
Results: Posted 23 Oct 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This is a study to assess the safety, tolerability, and PK of oral TPOXX 600 mg when administered twice daily (BID) for 28 days in adult subjects.

Detailed description

This is a Phase 3, multicenter, double-blind, randomized, placebo-controlled study to assess the safety, tolerability, and PK of oral TPOXX 600 mg when administered BID for 28 days in adult subjects.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
TPOXX	Active comparator	Drug: TPOXXTreatment Group 1: An oral dose of 600 mg (3 x 200 mg capsules)TPOXX
TPOXX Placebo	Placebo comparator	Other: TPOXX PlaceboTreatment Group 2: An oral dose of placebo (3 capsules identical to TPOXX)

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (18 listed)

Subject is male or female between 18 and 80 years of age, inclusive.
Subject is available for clinical follow-up for the duration of the study.
Women of childbearing potential have a negative beta human chorionic gonadotropin pregnancy test (serum) at the screening visit and a confirmatory negative pregnancy test on Day 1 or Day -1 (PK subset) before receipt of study drug, and meet one of the following criteria:
Male subjects must agree to not donate sperm from the first dose of study drug through 90 days after the last dose of study drug.
Subject is considered by the investigator to be in good general health as determined by medical history (no hospitalizations for chronic medical conditions in the previous 2 years), clinical laboratory test results, vital sign measurements, 12-lead ECG results, and physical examination findings at screening.

Key exclusion criteria (56 listed)

Subject is a female who is pregnant or breastfeeding or planning to become pregnant within 3 months after the last dose of study drug.
Subject has a history of any clinically significant conditions including:
Subject has received any vaccination within 28 days prior to Day 1 or plans to receive a vaccination at any time during the treatment period or within 28 days after study Day 28.
Subject has received treatment in another clinical study of an investigational drug (or medical device) or investigational vaccine within 30 days or 5 half-lives (whichever is longer) before the first dose of study drug.
Subject has a history of relevant drug and/or food allergies (ie, allergy to TPOXX or excipients, or any significant food allergy that could preclude a standard diet in the clinical investigative site).

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
TPOXXAlso: tecovirimatStudy is based on Animal Regulatory Rule	Drug	TPOXX
TPOXX PlaceboAlso: PlaceboDoes not apply	Other	TPOXX Placebo

Primary outcome

Cmin
Time frame: 28 days
Cmin - Minimum TPOXX concentration in plasma
Cmax
Time frame: 28 days
Peak exposure when administered TPOXX
AUC(0-last) - Total Systemic TPOXX Exposure
Time frame: 28 days
Total systematic exposure when administered TPOXX
Time To Maximum TPOXX Exposure
Time frame: 28 days
Median hours post dose when administered TPOXX

1 secondary outcome

Adverse Events
Time frame: 58 Days

Results and safety

Results posted to the registry on 23 Oct 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
TPOXX	372	329
TPOXX Placebo	95	86

Primary outcome: Cmin

Time frame: 28 days. Geometric mean (Geometric Coefficient of Variation). Unit: ng/mL

Measure	TPOXX Pharmacokinetic Population Day 28 n = 26
Value	792 (52.5)

Primary outcome: Cmax

Time frame: 28 days. Geometric mean (Geometric Coefficient of Variation). Unit: ng/mL

Measure	TPOXX Pharmacokinetic Population Day 28 n = 26
Value	1950 (45.1)

Primary outcome: AUC(0-last) - Total Systemic TPOXX Exposure

Time frame: 28 days. Geometric mean (Geometric Coefficient of Variation). Unit: ng*h/mL

Measure	TPOXX Pharmacokinetic Population Day 28 n = 26
Value	51100 (46.0)

Primary outcome: Time To Maximum TPOXX Exposure

Time frame: 28 days. Geometric mean (Full Range). Unit: hours

Measure	TPOXX Pharmacokinetic Population Day 28 n = 26
Value	4 (2.00 to 8.00)

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Adverse event data was collected from Day 1 though the Day 58 follow-up telephone call. All AEs were followed until stable or until resolution as determined by the investigator and/or medical monitor.. Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
TPOXX	1 of 369 (0.3%)	90 of 369 (24.4%)	0
TPOXX Placebo	1 of 95 (1.1%)	20 of 95 (21.1%)	0

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Smallpox

Active, not recruitingPhase 2
Study to Assess the Safety and Immunogenicity of TPOXX® When Administered Orally for 28 Days With JYNNEOS
Smallpox
Active, not recruitingPhase 4
Smallpox Vaccine for Mpox Post-Exposure Prophylaxis: A Cluster RCT
Monkeypox
RecruitingPhase 2
A Randomized Clinical Trial Investigating the Safety, Reactogenicity, and Immunogenicity After Immunization With an mRNA-based Mpox Vaccine Candidate in Africa
Mpox (Monkeypox), Smallpox
Enrolling by invitationObservational study
VA-005 Clinical Outcomes of VIGIV Treatment of Smallpox Vaccination Complications or Vaccinia Infection
Complication of Smallpox Vaccination
Active, not recruitingPhase 3
Phase 3 Infant Safety & Immunogenicity Trial of MVA-BN® in DRC
Mpox (Monkeypox), Vaccination

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Dennis Hruby study director

SIGA Technologies

9 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing TPOXX in people with Smallpox, run by SIGA Technologies at 9 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 56 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cmin (time frame: 28 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04971109.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2026.